NAFLD is a form of fat-induced inflammation of the liver which is present throughout the industrialized world. The prevalence of NAFLD ranges from 10% to 24% in the general population and NAFLD is the leading cause of cirrhosis, chronic liver failure, liver transplantation, and primary hepatic cancers in the United States. NAFLD is associated with metabolic syndrome (e.g., obesity, diabetes mellitus, hyperlipidemia, and/or hypertension), certain medications (e.g., estrogens, coumadin, tamoxifen, valproic acid, methotrexate, isoniazid, corticosteroids, Vitamin A, troglitazone, I-Asparaginase, amiodarone, perhexiline, calcium channel blockers, and/or nucleoside analogues), Hepatitis C, nutritional risk factors (e.g., rapid weight loss, total parenteral nutrition, starvation, and/or protein-calorie malnutrition), certain surgical procedures (e.g., gastrointestinal surgery for obesity and/or extensive small-bowel resection), metabolic disorders (e.g., cystic fibrosis and/or abetalipoproteinemia), syndromes associated with obesity and insulin resistance (e.g., lipodystrophies, hypopituitarism, and/or Prader-Willi syndrome), and various other conditions. With particular regard to obesity (a feature of metabolic syndrome), NAFLD is observed in up 75% of obese persons.
While there are medications approved for treating diseases and conditions associated with NAFLD, there are currently no medications specifically approved for the treatment of NAFLD itself. As a result, treatment protocols are focused upon the associated conditions, such as metabolic syndrome. For example, conventional treatment of NAFLD may include weight loss, restricting dietary fat, administration of medications employed in the treatment of an associated condition (e.g., metformin and thiazolidinediones), and administration of medications employed in the treatment of hyperlipidemia (e.g., HMG-Co-A inhibitors). However, in addition to there being no standard treatment specific to NAFLD, many medications employed to treat conditions associated with NAFLD are hepatotoxic.